Advanced intra-spinal decompression implant

ABSTRACT

A new Intra-spinal decompression implant is introduced that comprises of two plate attachments to a titanium metal implant that fits between the spinous processes of the vertebrae in the lower back, decompressing the neuro elements. The invention has a number of new design features including: double axis adjustable side plates, stepped conical tipped body and piercing tips on side plates, among many mentioned in this disclosure, that improves the quality of the surgery and the result for the patient. More examples are given in this application.

RELATED APPLICATIONS

This application is a CIP (continuation-in-part) of another application,application Ser. No. 12/245,717, filed Oct. 4, 2008, now U.S. Pat. No.8,236,030, with the same title and inventor, and it claims priority tothat parent application.

BACKGROUND OF THE INVENTION

An Intra-spinal decompression implant comprises of two plate attachmentsto a titanium metal implant that fits between the spinous processes ofthe vertebrae in the lower back, decompressing the neuro elements. Thesedevices are implanted without fixation to the bone or ligament topreserve physiological spinal motion. These devices are particularlyuseful for patients who suffer from degenerative disc disease, spinalstenosis, or lateral recess syndrome. Such device has many advantages,including easy installation and therefore capable of decompressing thespinal canal and nerve roots quickly and efficiently.

The Intra-spinal decompression implants available to date in the marketrequire different size of side plates and/or different size of implantbody for different spinal levels or different patients. They are alsoprone to moving from the intended location. The following Websiteprovides a good description of one the available Intra-spinaldecompression implants in the market:http://www.ispub.com/ostia/index.php?xmlFilePath=journals/ijmist/vol1n1/xstop.xml

This invention provides an improved design for Intra-spinaldecompression implants that unlike other decompression implants on themarket can be used on multiple spinal levels and different type ofpatients. The invented device will reduce surgery time by almost half anhour per spinal level and allows for the procedure to be done on localstandby and on an out-patient basis.

SUMMARY OF THE INVENTION

One embodiment of the present invention is an Intra-spinal decompressionimplant that comprises of two plate attachments to a titanium metalimplant that fits between the spinous processes of the vertebrae in thelower back, decompressing the neuro elements. The invention (as anexample) has a number of new design features, including:

-   -   Lateral and vertical side plate adjustments    -   An implant body capable of dual axis adjustment with a large        cavity for packing of bone graft material, for tissue to fuse        around and inside the device, for better installation (the        cavity can be multiple cavities, in middle, and small ones on        the sides, as one example)    -   The implant body design incorporates a stepped and pointed        conical tipped end, for better installation    -   Conical piercing tipped studs for attachment to the vertebrae    -   The implant design incorporates precision-machined slots and        keys in the implant body and side plates

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is the top view of the implant body that incorporates a steppedand pointed conical tipped end.

FIG. 2 illustrates one of the side plate attachments to the implantbody, with rear and front parts, in which the length of the front partis adjustable.

FIG. 3 is a cross section view of the implant body, which shows how theside plate is attached to the implant body as well as the bottom cavityof the implant body.

FIG. 4 shows the stepped and conical ripped end and its cross section.

FIG. 5 shows the dual axis (X and Y) adjustment mechanisms of theimplant.

FIG. 6 shows the locking and retaining fasteners for the side plateattachment.

FIG. 7 shows the large bottom cavity of the implant body. This exampleshows a hexagonal shaped cavity.

FIG. 8 shows the conical-shaped piercing tipped studs on the front andrear side plates.

FIG. 9 shows the slot and key mechanism used for dual axis adjustment ofthe implement.

FIG. 10 shows a symmetric and an asymmetric stepped tipped end of theimplant body.

FIG. 11 shows an asymmetric side plate, with different front and rearwings sizes.

FIG. 12 shows the screws and bands that support the structure for one ofthe embodiments.

FIG. 13 shows the cross section or another view of the structure shownin FIG. 12.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The Intra-spinal decompression implant of the preferred embodiment isshown in FIGS. 1, 2 and 3. It is designed for plate attachment to thetitanium metal implant and fits between the spinous processes of thevertebrae in the lower back, decompressing the neuro elements. It isdesigned to remain safely and permanently in place as the spinalprocesses gradually fuses together while the spine naturally repairsitself. The device is particularly useful for patients who suffer fromdegenerative disc disease, spinal stenosis, or lateral recess syndrome.The device has many advantages, including easy installation andtherefore capable of decompressing the spinal canal and nerve rootsquickly and inefficiently. Unlike other decompression implants on themarket, the side plates of the device are adjustable in two dimensions(FIG. 5), which allow them to be universally used on multiple spinallevels or different patients. The device will reduce surgery time byalmost half an hour per spinal level and allows for the procedure to bedone on local standby and on an out-patient basis.

The design includes implant adjustments in width and length toaccommodate the patient anatomy. Height adjustment is accomplished byreplacement of the implant body to a different diameter (larger orsmaller size). The side plates are universal and can be assembled with avariety of sizes. Lateral and vertical adjustment (length and width) isaccomplished by means of slots and keys (FIG. 9) that are machined inthe side plate and implant body.

Please note that Appendices 1-5, 6-7, and 8-31 show various components,installations, usages, and viewpoints of our system, in differentembodiments, for different applications. These are our own teachings forsupport of our spec and claims.

Design Features

The design incorporates the following features for trouble-freeimplantation:

-   -   Lateral and vertical side plate adjustment incorporating ¼-½        turn locking and retaining fasteners (FIG. 6) that enables        multiple positioning that accommodate a variable size range of        patient anatomy. The side plates could be quickly adjusted        before or during the surgery, therefore, reducing the operation        time. FIG. 1 shows the slots (103) that are used for lateral        adjustment of the side plates. There are typically 3 adjustment        slots for each of the side plates as shown in FIG. 1 (103). FIG.        2 shows one of the side plates, which has vertical adjustment        via a slot (206) and typically two screws (203).    -   An implant body that is capable of dual axis adjustment with a        large cavity (FIG. 7) for multiple purposes, which include        engaging the insertion handle, packing of bone graft material,        and reducing the weight of the implant as shown in FIG. 3. The        cavity has preferably an octagon or hexagon shape (301). The        implant body may come in different diameter and lengths to        accommodate different patient compositions. It could also be        made of different materials that may include non-corrosive        metals such as Titanium, plastic natural or man-made material.    -   The implant body design incorporates a stepped and pointed        conical tipped end as shown in FIGS. 1 and 3 that promotes        easier insertion into the patient (between the spinoud processes        of the vertebrae in the lower back) and prevents excessive        movement of the implant after surgery. The tipped end (102, 304)        may be asymmetric for easier insertion.    -   Conical piercing tipped studs (FIG. 8) on side plates for        attachment to the vertebrae and therefore reducing the chance of        the implant moving from its preferred spot shown in FIG. 2 (204,        205). Preferably two tipped studs are placed in the front (204)        and two on the rear (205) of each side plate.    -   The implant design incorporates precision-machined slots and        keys (103, 302, and 303) in the implant body and side plates to        obtain a smooth running and sliding fit that prevent binding and        allow for quick and easy adjustments in both lateral and        vertical directions to accommodate a variety of patient        compositions. The precision-machined slots allow for speedy and        symmetrical installation of side plates, and therefore, reducing        the operation time.

In one embodiment, the shape of the implant in 2 directions have 2different cross-sections, one much larger, being asymmetric, making itideal for locking and proper installation, for example, after rotationof the assembly by 90 degree, making sure that the device cannot beslide out (out of its intended position), for example, being locked atthat direction, for proper and long-lasting installation in the body.

In one embodiment, the plates can be adjusted for multiple levels forvertebral body.

In another embodiment, the size is adjustable for different sizepatients, making it cheaper to manufacture, and easier to install,because it does not have to be custom-made much before the surgery, foreach individual separately, based on his/her size and body structure.

In one embodiment, the side plates are asymmetrical and the front andrear end of the side plates have different size (FIG. 11).

More details are shown in the following figures: FIG. 12 shows thescrews and bands that support the structure for one of the embodiments.FIG. 13 shows the cross section or another view of the structure shownin FIG. 12.

Note that easy installation means faster surgery, which means bettersurvival rate after surgery.

Single Level Intra-Spinal Fusion:

The single level intra-spinal fusion is based on our multi-levelintra-spinal fusion instrument. Like the multi-level fusion device, thesingle level consists of:

1. A sharp tip for easy insertion.

2. A rotational capability to help increase the space between the spinalprocess, e.g. between 2-5 mm.

3. A hollow canal to allow for increased and robust fusion in the spinalprocess.

In addition to allowing for successful execution of a single levelintra-spinal fusion, this device can also be used for a facet fusion,specifically for patients with grade I and grade II spondyloisthesis.The device includes metal attachments that can be secured, via metalscrews, from the fusion device itself, to the facet joint, permittingfor successful facet fusion. See FIGS. 12-13 for details, in addition toappendices for more pictures and drawings. FIG. 12 shows the structurewith metal (or other materials) bands (or arrays or series of bands) orstripes attached (slightly bended or curved for most configurations),holding or attaching or supporting the components, using two screws atthe 2 ends (or similar attachment mechanisms).

The attachments with screws, holes, slots, and pins make the sizeadjustable for different patients and sizes.

Any material, such as plastic, titanium, alloy, metal, elastic, humantissue, animal tissue, cultured material, plant-based, oil-based,petrochemical, cotton, fabric, any byproducts, magnetic, non-magnetic,alloyed, plated, implanted, mix, powder, combination, mixture, andsimilar types, can be used.

The attachments can be done by screws, holes, slots, pins, ribbon,string, chain, cable, rings, human tissue, engineered tissue, glue,pressured material, Velcro-type, micro-sized devices, nano-fabricatedmaterial and devices, using only surface adhesion, using micro-propertyof materials, welded joints, hinges, locks, engagements devices, keys,and similar types.

Any variations of the above are also meant to be covered by the currentpatent application.

The invention claimed is:
 1. An apparatus for decompressing spinal neuro elements, said apparatus comprising: an implant body; wherein said implant body has an asymmetric cross section; said implant body comprises two parallel flat sides and two curved sides; minimum distance between said two parallel flat sides is smaller than minimum distance between said two curved sides; said implant body comprises a base with a hexagonal cavity; said implant body comprises a tip with a stepped and pointed conical shape; said implant body comprises holes for screws to get attached to said implant body and one or more grooves; two side plates are attached to said implant body, wherein said two side plates are positioned in parallel; minimum distance between said two side plates is adjustable, wherein each of said two side plates comprises one or more slots for adjusting position of said two side plates in lateral and vertical directions with respect to said implant body; length of each of said side plates is adjustable; each of said two side plates comprises one or more conical piercing tipped studs for attachment to human body or tissue; and one or more stripes; wherein said one or more stripes are attached to said two side plates and tissue using two screws at two ends of each of said one or more stripes.
 2. The apparatus as stated in claim 1, wherein said implant body and said two side plates are made from metal, alloy, plastic, elastic, natural, titanium or man-made material.
 3. The apparatus as stated in claim 1, wherein said apparatus has a rough surface or small extensions for better friction, adhesion, and incorporation to said human body or tissue.
 4. The apparatus as stated in claim 1, wherein said one or more stripes are bent.
 5. The apparatus as stated in claim 1, wherein said one or more stripes are straight.
 6. An apparatus for decompressing spinal neuro elements, said apparatus comprising: an implant body; wherein said implant body has an asymmetric cross section; said implant body comprises two parallel flat sides and two curved sides; minimum distance between said two parallel flat sides is smaller than minimum distance between said two curved sides; said implant body comprises a base with a hexagonal cavity; said implant body comprises a tip with a stepped and pointed conical shape; said implant body comprises one or more grooves and holes for screws to get attached to said implant body; two side plates; wherein said two side plates are positioned in parallel; said two side plates are attached to said implant body; minimum distance between said two side plates is adjustable, wherein each of said two side plates comprises one or more slots for adjusting position of said two side plates in dual directions with respect to said implant body; each of said two side plates comprises one or more conical piercing tipped studs for attachment to human body or tissue; and one or more stripes; wherein said one or more stripes are attached to said two side plates and tissue using two screws at two ends of each of said one or more stripes.
 7. The apparatus as stated in claim 6, wherein said one or more stripes are four stripes.
 8. The apparatus as stated in claim 6, wherein said implant body and said two side plates are made from metal, alloy, plastic, elastic, natural, titanium or man-made material.
 9. The apparatus as stated in claim 6, wherein said apparatus has a rough surface or small extensions for better friction, adhesion, and incorporation to said human body or tissue.
 10. The apparatus as stated in claim 6, wherein said one or more stripes are bent.
 11. The apparatus as stated in claim 6, wherein said one or more stripes are straight. 